What does Form FDA 1571 represent?

Form FDA 1571 represents the Investigational New Drug Application (IND) submission to the FDA. This form is a critical document in the regulatory process for drug development. It is required when a sponsor seeks to initiate clinical trials for a new drug product intended for human use.

The IND application essentially contains information about the drug's formulation, manufacturing, pharmacology, toxicology, and the proposed clinical study design. By submitting Form FDA 1571, the sponsor is formally requesting FDA authorization to administer the investigational drug to humans, which is essential for ensuring the safety and efficacy of the drug before it can enter the market.

In summary, Form FDA 1571 serves as a key administrative document to communicate vital information about the clinical investigation of new drugs to the FDA, laying the foundation for conducting clinical trials.